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Apyx Medical Corporation

Company NameApyx Medical Corporation
Stock SymbolAPYX
Class PeriodMay 12, 2021 to March 11, 2022
Lead Plaintiff Motion DeadlineAugust 05, 2022

On March 14, 2022, Apyx disclosed that the U.S. Food and Drug Administration (“FDA”) would be posting a Medical Device Safety Communication (“MDSC”) related to the Company’s Advanced Energy Products. The Company further disclosed that “[b]ased on our initial interactions with the FDA, we believe the Agency’s MDSC will pertain to the use of our Advanced Energy products outside of their FDA-cleared indication for general use in cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.”

On this news, the Company’s stock fell $4.02, or 40.6%, to close at $5.88 per share on March 14, 2022, on unusually heavy trading volume.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that a significant number of Apyx’s Advanced Energy products were used for off-label indications; (2) that such off-label uses led to an increase in the number of medical device reports filed by Apyx reporting serious adverse events; (3) that, as a result, the Company was reasonably likely to incur regulatory scrutiny; (4) that, as a result of the foregoing, the Company’s financial results would be adversely impacted; and (5) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

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